Duns Number:826110710
Device Description: PV-6-20-HELIX CONCERTO HELIX COIL PGLA
Catalog Number
-
Brand Name
ConcertoTM
Version/Model Number
PV-6-20-HELIX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090046
Product Code
KRD
Product Code Name
Device, Vascular, for Promoting Embolization
Public Device Record Key
c27d7832-d1f4-4554-a1a7-8777aca09b15
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1759 |
3 | A medical device with high risk that requires premarket approval | 562 |